Aldrich Chemical Company, LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Aldrich Chemical Company, LLC has 0 FDA recalls, 5 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Aldrich Chemical Company, LLC" is on file.

What these totals cover: FDA records filed under the name "Aldrich Chemical Company, LLC" and its spelling variants "Aldrich Chemical Company", "Aldrich Chemical Co".

Latest inspection
Apr 26, 2023 · NAI
Latest 510(k)
Nov 29, 1983

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Aldrich Chemical Company, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Aldrich Chemical Company, LLC: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202110000
202000000
201900000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

5 inspections from Sep 3, 2009 to Apr 26, 2023.

DateSiteProductClassificationFEI
Apr 26, 2023Sheboygan Falls, WIFood/CosmeticsNo Action Indicated (NAI)2131051
Jul 21, 2021Milwaukee, WIFood/CosmeticsNo Action Indicated (NAI)3013296182
May 30, 2018Sheboygan Falls, WIFood/CosmeticsNo Action Indicated (NAI)2131051
Dec 6, 2011Sheboygan Falls, WIFood/CosmeticsNo Action Indicated (NAI)2131051
Sep 3, 2009Sheboygan Falls, WIDrugsNo Action Indicated (NAI)2131051
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 2131051Sheboygan Falls, WI4Apr 26, 2023
FEI 3013296182Milwaukee, WI1Jul 21, 2021

Recent 510(k) clearances

2 510(k) clearances from Nov 28, 1983 to Nov 29, 1983.

K-NumberDeviceDate
K833493DISPOSABLE SYRINGES & NEEDLESNov 29, 1983
K833460SYRINGE,PISTON NEEDLE, HOLLOW LUMENNov 28, 1983

Aldrich Chemical Company, LLC and the FDA: common questions

Has Aldrich Chemical Company, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Aldrich Chemical Company, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Aldrich Chemical Company, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Aldrich Chemical Company, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Aldrich Chemical Company, LLC?

The most recent FDA inspection on file ended Apr 26, 2023 at Sheboygan Falls, WI and was classified NAI. FDA has 5 inspections of Aldrich Chemical Company, LLC on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.